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ViroPharma

ViroPharma Incorporated was a pharmaceutical company that developed and sold drugs that addressed serious diseases treated by physician specialists and in hospital settings. The company focused on product development activities on viruses and human disease, including those caused by cytomegalovirus (CMV) and hepatitis C virus (HCV) infections. It was purchased by Shire in 2013, with Shire paying around $4.2 billion for the company in a deal that was finalized in January 2014.[2] ViroPharma was a member of the NASDAQ Biotechnology Index and the S&P 600.

ViroPharma Incorporated
Company typePublic NASDAQ Biotechnology Index
Nasdaq: VPHM
IndustryHealthcare, Biotechnology, Pharmaceutical company
FoundedExton, Pennsylvania, U.S. (1994)
FounderClaude H. Nash
Mark A. McKinlay
Marc S. Collett
Johanna A. Griffin
Guy D. Diana
Defunct2014
HeadquartersExton, Pennsylvania, U.S.
Key people
Vincent Milano
(Chairman and CEO)
ProductsVancocin
Revenue132,417,000 USD (2005)
88,145,000 USD (2005)
113,705,000 USD (2005)
Number of employees
232[1]
Websitewww.viropharma.com

The company had strategic relationships with GlaxoSmithKline, Schering-Plough, and Sanofi-Aventis. ViroPharma acquired Lev Pharmaceuticals in a merger in 2008.[3][4]

History edit

ViroPharma Incorporated was founded in 1994 by Claude H. Nash (Chief Executive Officer), Mark A. McKinlay (Vice President, Research & Development), Marc S. Collett (Vice President, Discovery Research), Johanna A. Griffin (Vice President, Business Development), and Guy D. Diana (Vice President, Chemistry Research.) None of the founders are still with the company.

In November 2014, Shire plc acquired ViroPharma for $4.2 billion.[5]

Products edit

Marketed products edit

Vancocin Pulvules HCl: licensed from Eli Lilly in 2004.[6] Oral Vancocin is an antibiotic for treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis caused by Clostridium difficile.

Pipeline edit

Maribavir is an oral antiviral drug candidate licensed from GlaxoSmithKline in 2003 for the prevention and treatment of human cytomegalovirus disease in hematopoietic stem cell/bone marrow transplant patients. In February 2006, ViroPharma announced that the United States Food and Drug Administration (FDA) had granted the company fast track status for maribavir.[7][8]

In March 2006, the company announced that a Phase II study with maribavir demonstrated that prophylaxis with maribavir displays strong antiviral activity, as measured by statistically significant reduction in the rate of reactivation of CMV in recipients of hematopoietic stem cell/bone marrow transplants. In an intent-to-treat analysis of the first 100 days after the transplant, the number of subjects who required pre-emptive anti-CMV therapy was statistically significantly reduced (p-value = 0.051 to 0.001) in each of the maribavir groups compared to the placebo group (57% for placebo vs. 15%, 30%, and 15% for maribavir 100 mg twice daily, 400 mg daily, and 400 mg twice daily, respectively).

ViroPharma conducted a Phase III clinical study to evaluate the prophylactic use for the prevention of cytomegalovirus disease in recipients of allogeneic stem cell transplant patients. In February 2009, ViroPharma announced that the Phase III study failed to achieve its goal, showing no significant difference between maribavir and a placebo in reducing the rate of CMV disease.[9]

Failed products edit

Oral pleconaril was ViroPharma's first compound, licensed from Sanofi in 1995. Pleconaril is active against viruses in the picornavirus family. ViroPharma's first indication was for enteroviral meningitis, but that indication was abandoned when the clinical trials did not demonstrate efficacy.

In 2001, ViroPharma submitted a New Drug Application of pleconaril to the FDA for the common cold.[10] On 2002-03-19, the FDA Antiviral Advisory Committee recommended that the company had failed to show adequate safety, and the FDA subsequently issued a not-approvable letter.[11]

In November 2004, ViroPharma licensed pleconaril to Schering-Plough,[12] who are developing an intranasal formulation for the common cold and asthma exacerbations. (Schering-Plough Development Pipeline). In August 2006, Schering-Plough started a Phase II clinical trial.

References edit

  1. ^ "Symbol Lookup from Yahoo Finance". finance.yahoo.com.
  2. ^ "Shire acquires ViroPharma for $4.2bn". Financier Worldwide. Retrieved 23 April 2020.
  3. ^ Staff (15 July 2008). "ViroPharma to Purchase Lev for $442.9M". Genetic Engineering & Biotechnology News. GEN News Highlights. Mary Ann Liebert. ISSN 1937-8661. Retrieved 26 September 2008.
  4. ^ "Lev Pharmaceuticals Investor Relations". Lev Pharmaceuticals. Retrieved 8 April 2009.
  5. ^ Kitamura, Makiko (11 November 2013). "Shire Buys ViroPharma for $4.2 Billion to Add Orphan Drug". Bloomberg.
  6. ^ Pollack, Andrew (9 November 2005). "Crucial Antibiotic Rescues Biotech Maker's Finances". The New York Times. Retrieved 20 September 2007.
  7. ^ "FDA GRANTS FAST-TRACK STATUS FOR VIROPHARMA'S MARIBAVIR". www.fdanews.com. Retrieved 19 August 2020.
  8. ^ "FDA grants fast track status for ViroPharma's Maribavir | health.am". Retrieved 19 August 2020.
  9. ^ ViroPharma:Maribavir Phase III Study Missed Goal;Shares Plunge 12 February 2009 at the Wayback Machine, CNN Money, 9 February 2009
  10. ^ Freundlich, Naomi (3 February 2002). "On the Trail of a Cure For the Common Cold". The New York Times. Retrieved 20 September 2007.
  11. ^ Pollack, Andrew (20 March 2002). "F.D.A. Panel Opposes Drug Meant to Treat Cause of Colds". The New York Times. Retrieved 20 September 2007.
  12. ^ "Picornaviruses and Schering-Plough" (PDF). Retrieved 23 December 2023.

Further references edit

  • The Long Road Ahead for ViroPharma Motley Fool 29 September 2006

External links edit

  • viropharma.com

viropharma, incorporated, pharmaceutical, company, that, developed, sold, drugs, that, addressed, serious, diseases, treated, physician, specialists, hospital, settings, company, focused, product, development, activities, viruses, human, disease, including, th. ViroPharma Incorporated was a pharmaceutical company that developed and sold drugs that addressed serious diseases treated by physician specialists and in hospital settings The company focused on product development activities on viruses and human disease including those caused by cytomegalovirus CMV and hepatitis C virus HCV infections It was purchased by Shire in 2013 with Shire paying around 4 2 billion for the company in a deal that was finalized in January 2014 2 ViroPharma was a member of the NASDAQ Biotechnology Index and the S amp P 600 ViroPharma IncorporatedCompany typePublic NASDAQ Biotechnology IndexTraded asNasdaq VPHMIndustryHealthcare Biotechnology Pharmaceutical companyFoundedExton Pennsylvania U S 1994 FounderClaude H NashMark A McKinlayMarc S CollettJohanna A GriffinGuy D DianaDefunct2014HeadquartersExton Pennsylvania U S Key peopleVincent Milano Chairman and CEO ProductsVancocinRevenue132 417 000 USD 2005 Operating income88 145 000 USD 2005 Net income113 705 000 USD 2005 Number of employees232 1 Websitewww viropharma comThe company had strategic relationships with GlaxoSmithKline Schering Plough and Sanofi Aventis ViroPharma acquired Lev Pharmaceuticals in a merger in 2008 3 4 Contents 1 History 2 Products 2 1 Marketed products 2 2 Pipeline 2 3 Failed products 3 References 3 1 Further references 4 External linksHistory editViroPharma Incorporated was founded in 1994 by Claude H Nash Chief Executive Officer Mark A McKinlay Vice President Research amp Development Marc S Collett Vice President Discovery Research Johanna A Griffin Vice President Business Development and Guy D Diana Vice President Chemistry Research None of the founders are still with the company In November 2014 Shire plc acquired ViroPharma for 4 2 billion 5 Products editMarketed products edit Vancocin Pulvules HCl licensed from Eli Lilly in 2004 6 Oral Vancocin is an antibiotic for treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis caused by Clostridium difficile Pipeline edit Maribavir is an oral antiviral drug candidate licensed from GlaxoSmithKline in 2003 for the prevention and treatment of human cytomegalovirus disease in hematopoietic stem cell bone marrow transplant patients In February 2006 ViroPharma announced that the United States Food and Drug Administration FDA had granted the company fast track status for maribavir 7 8 In March 2006 the company announced that a Phase II study with maribavir demonstrated that prophylaxis with maribavir displays strong antiviral activity as measured by statistically significant reduction in the rate of reactivation of CMV in recipients of hematopoietic stem cell bone marrow transplants In an intent to treat analysis of the first 100 days after the transplant the number of subjects who required pre emptive anti CMV therapy was statistically significantly reduced p value 0 051 to 0 001 in each of the maribavir groups compared to the placebo group 57 for placebo vs 15 30 and 15 for maribavir 100 mg twice daily 400 mg daily and 400 mg twice daily respectively ViroPharma conducted a Phase III clinical study to evaluate the prophylactic use for the prevention of cytomegalovirus disease in recipients of allogeneic stem cell transplant patients In February 2009 ViroPharma announced that the Phase III study failed to achieve its goal showing no significant difference between maribavir and a placebo in reducing the rate of CMV disease 9 Failed products edit Main article Pleconaril Oral pleconaril was ViroPharma s first compound licensed from Sanofi in 1995 Pleconaril is active against viruses in the picornavirus family ViroPharma s first indication was for enteroviral meningitis but that indication was abandoned when the clinical trials did not demonstrate efficacy In 2001 ViroPharma submitted a New Drug Application of pleconaril to the FDA for the common cold 10 On 2002 03 19 the FDA Antiviral Advisory Committee recommended that the company had failed to show adequate safety and the FDA subsequently issued a not approvable letter 11 In November 2004 ViroPharma licensed pleconaril to Schering Plough 12 who are developing an intranasal formulation for the common cold and asthma exacerbations Schering Plough Development Pipeline In August 2006 Schering Plough started a Phase II clinical trial References edit Symbol Lookup from Yahoo Finance finance yahoo com Shire acquires ViroPharma for 4 2bn Financier Worldwide Retrieved 23 April 2020 Staff 15 July 2008 ViroPharma to Purchase Lev for 442 9M Genetic Engineering amp Biotechnology News GEN News Highlights Mary Ann Liebert ISSN 1937 8661 Retrieved 26 September 2008 Lev Pharmaceuticals Investor Relations Lev Pharmaceuticals Retrieved 8 April 2009 Kitamura Makiko 11 November 2013 Shire Buys ViroPharma for 4 2 Billion to Add Orphan Drug Bloomberg Pollack Andrew 9 November 2005 Crucial Antibiotic Rescues Biotech Maker s Finances The New York Times Retrieved 20 September 2007 FDA GRANTS FAST TRACK STATUS FOR VIROPHARMA S MARIBAVIR www fdanews com Retrieved 19 August 2020 FDA grants fast track status for ViroPharma s Maribavir health am Retrieved 19 August 2020 ViroPharma Maribavir Phase III Study Missed Goal Shares Plunge Archived 12 February 2009 at the Wayback Machine CNN Money 9 February 2009 Freundlich Naomi 3 February 2002 On the Trail of a Cure For the Common Cold The New York Times Retrieved 20 September 2007 Pollack Andrew 20 March 2002 F D A Panel Opposes Drug Meant to Treat Cause of Colds The New York Times Retrieved 20 September 2007 Picornaviruses and Schering Plough PDF Retrieved 23 December 2023 Further references edit The Long Road Ahead for ViroPharma Motley Fool 29 September 2006 nbsp Companies portalExternal links editviropharma com Retrieved from https en wikipedia org w index php title ViroPharma amp oldid 1191411022, wikipedia, wiki, book, books, library,

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